Manufacturing Associate

2 months ago

Winnipeg, Manitoba, Canada Emergent BioSolutions Inc. Full time
Job Summary

Fosters a culture of excellence in operations and assumes shift leadership when the Supervisor is not present. Performs and coordinates manufacturing, environmental monitoring, and equipment/facility cleaning/sanitization in a cGMP environment. Qualified trainer for manufacturing processes.

Responsibilities
  • Identifies and champions process improvement initiatives.
  • Assumes shift leadership role in the absence of the Supervisor, independently directing the activities of other Manufacturing Technicians to meet production schedule requirements.
  • Designs manufacturing process studies and reports on the findings.
  • Participates in cross-functional project teams.
  • Leads and contributes to the implementation of routine and complex process improvement, document, and change initiatives.
  • Performs root cause analysis to investigate manufacturing deviations, initiates and authors Standard Operating Procedures and Batch Production Records, and coordinates corrective actions/preventative actions.
  • Reviews all documentation generated as each step is completed for accuracy of calculations/data entry and completeness of process signature steps.
  • Qualified Trainer for Manufacturing process execution: adaptable to the learning style of the trainee, gives timely and candid performance feedback, and coordinates training and progression plan for Assistant and Technician level employees.
  • Maintains training/competence on Technician and Lead Technician level job tasks and executes as required.
  • Executes and documents procedural steps in compliance with cGMP standards, clean room behavior, and aseptic technique Standard Operating Procedures.
  • Maintains state of facility environmental control, including preparation of cleaning solutions, daily, monthly, quarterly, and annual cleaning of manufacturing surfaces and equipment per Standard Operating Procedures.
  • Performs daily assignments with minimal to no supervision.
  • Coordinates with Quality for straightforward manufacturing hurdles or provides a list of potential actions to remediate the issue for Supervisor/Manager to decide on.
Requirements
  • High school Diploma or equivalent required; Pharmaceutical manufacturing diploma or Bachelors' degree in Science/Engineering considered an asset.
  • Minimum of 4 years of related experience required; previous experience working in a regulated environment required.
  • Knowledge of cGMP and CFR requirements.
  • Ownership: actively participates in self-development.
  • Accountability: follows through on commitments.
  • Detail Oriented: able to complete required tasks and associated documentation with minimal error.
  • Adaptability: maintains a positive attitude in a changing work environment.
  • Communication: effectively communicates with all levels of manufacturing and support staff.
  • Participates in department/level meetings, escalates issues through proper channels, and adapts to and completes shift work including days, evening, and nights.
  • Able to work on ladders or at heights when required, lift and move materials/equipment when needed, pass a pre-employment medical and criminal background check, and adapt to and complete shift work including days, evening, and nights.
About Us

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements, and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our privacy policy.

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